Tiêu chuẩn iso 03826 1 2013

© ISO 2013 Plastics collapsible containers for human blood and blood components — Part 1 Conventional containers Poches en plastique souple pour le sang et les composants du sang — Partie 1 Poches con[.]

Plastics collapsible containers for

human blood and blood components — Part 1:

Reference numberISO 3826-1:2013(E)

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ISO 3826-1:2013(E)

Foreword iv

Introduction v

1 Scope 1

2 Normative references 1

3 Terms and definitions 1

4 Dimensions and designation 2

4.1 Dimensions 2

4.2 Designation example 2

5 Design 2

5.1 General 2

5.2 Air content 2

5.3 Emptying under pressure 2

5.4 Pilot samples 2

5.5 Rate of collection 3

5.6 Collection and transfer tube(s) 5

5.7 Blood-taking needle 5

5.8 Outlet port(s) 6

5.9 Suspension 6

6 Requirements 6

6.1 General 6

6.2 Physical requirements 7

6.3 Chemical requirements 8

6.4 Biological requirements 9

7 Packaging 10

8 Labelling 10

8.1 General 10

8.2 Label on plastics container 10

8.3 Label on over-package 11

8.4 Label on shipping box 11

8.5 Label requirements 11

9 Anticoagulant and/or preservative solution 12

Annex A (normative) Chemical tests 13

Annex B (normative) Physical tests 18

Annex C (normative) Biological tests 20

Bibliography 23

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards Draft International Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights ISO shall not be held responsible for identifying any or all such patent rights

ISO 3826-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and

blood processing equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 3826-1:2003), of which it constitutes a minor revision with the following changes:

— Figure 1 on the schematic representation of plastics containers has been updated;

— Table 1 has been amended to include a plastics container with a nominal capacity of 600 ml;

— subclause 5.6.5 on requirements for sterile connection transfer tubing has been added;

— subclause 5.8.1 on the outlet port(s) has been amended by a specification for placement of the septum and by a Note 2;

— subclauses 5.8.3 and 5.8.4 on further requirements for the outlet port(s) have been added;

— Clause B.5 on a test for sterile connection of tubing has been added;

— Annex C on biological tests has been completely revised and shortened in order to incorporate the linkage to the ISO 10993 series;

— the Bibliography has been updated;

— minor editorial changes have been made throughout the whole document

ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human

blood and blood components:

— Part 1: Conventional containers

— Part 2: Graphical symbols for use on labels and instruction leaflets

— Part 3: Blood bag systems with integrated features

The following parts are under preparation:

— Part 4: Aphaeresis blood bag systems with integrated features

ISO 3826-1:2013(E)

Introduction

In some countries, national pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this part of ISO 3826

The manufacturers of the plastics container, or the suppliers, are expected to disclose in confidence

to the national control authority, if requested by them, full details of the plastics material(s) and the components of the materials and their methods of manufacture, details of manufacture of the plastics containers, including the chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastics containers or present in the raw material, as well as full details of any additives that have been used

Universal leucocyte depletion is mandatory in various countries This part of ISO 3826 is considered a basic document for other standards which include technical innovations

The requirements in this part of ISO 3826 are intended to

a) ensure that the quality of blood and blood components is maintained as high as necessary,

b) make possible efficient and safe collection, identification, storage, separation, and transfusion of the contents, with special attention to reducing or minimizing the risks resulting from

— contamination, in particular, microbiological contamination,

— air embolism,

— errors in identification of plastics containers and any representative samples of contents,

— interaction between the plastics container and its contents,

c) ensure functional compatibility when used in combination with transfusion sets as specified in ISO 1135-4,

d) provide a package with appropriate resistance to breakage and deterioration

Plastics collapsible containers for human blood and

This part of ISO 3826 is also applicable to multiple units of plastics containers, e.g to double, triple, quadruple, or multiple units

Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as prepared ready for use

This part of ISO 3826 is not applicable to plastics containers with an integrated filter

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies

ISO 1135-4:2012, Transfusion equipment for medical use — Part 4: Transfusion sets for single use

ISO 3696:1987, Water for analytical laboratory use — Specification and test methods

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

Figure 1 illustrates the components of a plastics container The values of the dimensions shown in

Figure 1 are binding and form part of the requirements of this part of ISO 3826; the dimensions given

in Table 1 are for guidance only

4.2 Designation example

Plastics containers are designated using the descriptor words “Plastics container” followed by the number of this part of ISO 3826, followed by the nominal capacity of the container, in millilitres For example, the designation of a plastics container with a nominal capacity of 500 ml in accordance with this part of ISO 3826 is

Plastics container ISO 3826-1:2013, 500

5 Design

5.1 General

The design and manufacture of the plastics container shall provide for the safe and convenient collection, storage, processing, transport, separation, and administration of whole blood and blood components The plastics container shall permit the collection of blood and the preparation of plasma or centrifuged

or resuspended cellular components with a minimal hazard of contamination by microorganisms The plastics container shall be functionally compatible with the transfusion set specified in ISO 1135-4 Its design shall also ensure that it can be used in a centrifuge cup

5.2 Air content

5.2.1 The total volume of air contained in the plastics container system divided by the number of

containers shall not exceed 15 ml

5.2.2 When used in accordance with the manufacturer’s instructions, the plastics container shall be

capable of being filled with blood without air being introduced

5.3 Emptying under pressure

The plastics container, when filled with a volume of water at a temperature of (23 ± 5) °C equal to its nominal capacity and connected to a transfusion set as specified in ISO 1135-4 inserted in an outlet port (see 5.8), shall empty without leakage within 2 min when gradually squeezed between two plates to an internal pressure of 50 kPa above atmospheric pressure

5.4 Pilot samples

The plastics container shall be designed so that pilot samples of unmistakable identity can be collected for the performance of compatibility tests without the closed system of the plastics container being penetrated This may be accomplished, e.g by using an unmistakable numbering system on the tubing

ISO 3826-1:2013(E)

5.5 Rate of collection

The plastics container shall be designed so that it is capable of being filled to its nominal capacity in less than 8 min when tested in accordance with B.2

Dimensions in millimetres

Key

Figure 1 — Schematic representation of plastics container

5.6 Collection and transfer tube(s)

5.6.1 The plastics container may be provided with one or more collection or transfer tube(s) to allow

the collection and separation of blood and blood components

If a transfer tube is present, and if necessary to avoid unexpected flow between containers, it shall be fitted with a device which first acts as a seal and then, when broken, permits the free flow of blood components in either direction

5.6.2 The tubes shall be such that they can be sealed hermetically and do not collapse under normal use 5.6.3 The plastics container, filled with water to its nominal capacity and sealed, and the tubes connected

to the plastics container shall form a hermetic seal and a tight leakproof joint (see Note in 6.2.7) which will withstand, without leakage occurring, a tensile force of 20 N applied to the tubing for 15 s The tensile force shall be applied at right angles to the edge of the joint and along the longitudinal axis of the plane of the plastics container at a temperature of (23 ± 5) °C

There shall be no leakage at the junctions and the plastics container shall also conform to the requirements specified in 6.2.7

5.6.4 Under visual inspection, the tubing shall not display cracks, blisters, kinks, or other defects 5.6.5 Requirements for sterile connection of transfer tubing: Tubing design shall allow the efficient

transfer of blood and blood components between packs Design should also allow the joining of tubes supplied by a single manufacturer or from different manufacturers using a sterile tube welding device Typically, this is to enable the connection of separate satellite packs when preparing blood components

by a ‘secondary process’ Sterile tube welding devices join the two opposing ends of the tube while maintaining a sterile fluid pathway

Manufacturers of sterile tube welding devices typically specify acceptable tube dimensions (external and/or internal diameter and wall thickness) for use on their equipment Blood bag manufacturers must specify in their product documentation the material, internal and external diameters, and wall thickness of all their tubing to allow blood transfusion services to assess the suitability for tube welding.When a blood transfusion service wishes to weld tubing of different specifications, they should carry out a validation before proceeding A protocol is provided (see Clause B.5) as a minimum standard for such validations (see also Reference[5])

5.7 Blood-taking needle

The blood-taking needle shall be integral with the collection tube and covered by a protective cap The protective cap shall prevent leakage of anticoagulant and/or preservative solution from the plastics container during storage, shall maintain the sterility of the fluid path, and shall be readily removable The protective cap shall be tamper-evident and manufactured so that either it is impossible to replace

or any attempt at manipulating it is blatantly obvious

The internal and external surfaces of the blood-taking needle shall be clean and smooth The bevel of the needle shall be sharp and free from ridges, burrs, and barbs.

The joint between the blood-taking needle and the needle hub shall withstand a static tensile (pull) force and compressive (push) force of 20 N for 15 s along the longitudinal axis

The blood-taking needle may contain a needle-stick protection device in accordance with ISO 3826-3

5.8 Outlet port(s)

5.8.1 The plastics container shall be provided with one or more outlet ports for the administration

of blood and blood components through a transfusion set The port(s), which shall have a puncturable non-resealable closure port septum placed (14 ± 2) mm from the top of the port, shall allow connection

of a transfusion set having a closure-piercing device in accordance with ISO 1135-4 without leakage on insertion or during conditions of use, including emptying under pressure (see 5.3) Before the closure

is pierced by the point of the closure-piercing device, the outlet port(s) shall be tightly occluded by the closure-piercing device When used in accordance with manufacturer’s instructions, the piercing device shall not damage the plastic film of the plastics container on insertion

NOTE 1 For the dimensions of the closure-piercing device, see ISO 1135-4

NOTE 2 When designing the outlet port to ensure good compatibility with closure-piercing devices, manufacturers should avoid the use of tubing that is highly inflexible Thin-walled tubing (<1 mm) should also be avoided as this tends to twist and collapse on insertion

5.8.2 Each outlet port shall be fitted with a hermetically sealed, tamper-evident protector to maintain

the sterility of the internal surface

5.8.3 When a closure-piercing device conforming to ISO 1135-4 is inserted into the blood bag port, this

shall resist a pull force of 15 N for 15 s

5.8.4 When tested in accordance with 5.3, the connection between the closure-piercing device and the blood bag port shall show no evidence of leakage

5.9 Suspension

The plastics container shall have adequate means of suspension or positioning (see, for example, eyelets

in Figure 1) which do not interfere with the use of the plastics container during collection, storage, processing, transport, and administration The means of suspending or positioning the container shall

be capable of withstanding a tensile force of 20 N applied along the longitudinal axis of the outlet port(s) for 60 min at a temperature of (23 ± 5) °C without breaking

6 Requirements

6.1 General

The plastics container shall be transparent, virtually colourless (see 6.2.4), flexible, sterile, pyrogenic, biologically safe (see 6.4), and non-frangible under conditions of use (see 6.2.5) It shall be compatible with the contents under normal conditions of storage The plastics container shall meet the requirements for terminal sterilization and shall not become tacky during sterilization and storage for its shelf life at temperatures not exceeding 40 °C

non-The plastics container shall be stable biologically, chemically, and physically with respect to its contents during its shelf life and shall not permit penetration of microorganisms Any substances leached from the plastics container by the contained anticoagulant and/or preservative solution, blood, and blood components by either chemical interaction or physical dissolution, shall be within the limits specified

ISO 3826-1:2013(E)

In many countries, national pharmacopoeias specify formulations of different plastics materials, such

as flexible PVC with different plasticizers and other plastics materials, while government regulations or standards may detail suitable tests for assessing chemical or physical interactions

6.2 Physical requirements

6.2.1 Conditions of manufacture

All processes involved in the manufacture, assembly, and storage of the plastics container shall be carried out under clean and hygienic conditions in compliance with the appropriate national regulations, in accordance with relevant legislation and international agreements, such as current GMP requirements.[3]Every practicable precaution shall be taken at all stages to reduce the risk of adventitious contamination

by microorganisms or foreign matter

6.2.2 Sterilization

6.2.2.1 The plastics container shall have been sterilized by steam sterilization or any other validated

method

6.2.2.2 The method of sterilization used shall not adversely affect the materials or contents, nor cause

any loosening of joints and deterioration of welds in the plastics material nor any major alteration in the shape of the plastics container

6.2.2.3 The manufacturer shall be able to produce evidence acceptable to the national control authority

of the effectiveness of the sterilization process actually used If required by the national control authority, positive controls to check the effectiveness of sterilization shall be included in each sterilization lot

6.2.3 Transparency

When tested as specified in B.1, the opalescence of the suspension shall be perceptible when viewed through the plastics container as compared with a similar plastics container filled with water

6.2.4 Coloration

The material of the sterilized plastics container shall not be coloured to such an extent that assessment

of the colour of the blood is adversely affected

6.2.5 Thermal stability

This requirement refers primarily to plasma-freezing bags

The plastics container, filled to half of its nominal capacity with water as specified in ISO 3696, shall withstand a slow freezing to and storage at −80 °C for 24 h, subsequent immersion in water at (37 ± 2) °C for 60 min, and returning to room temperature The plastics container shall meet the requirements of

5.6.3, 5.9, 6.2.7, and 6.2.8 Plastics containers intended to be shock-frozen (blast-frozen) or irradiated shall be validated for those specific applications

If a refrigerant solution is used, the plastics container may be enclosed in a protective bag to avoid direct contact between the refrigerant solution and the plastics container

6.2.6 Water vapour transmission

The plastics container, without an over-package, shall be filled to its nominal capacity with water as specified in ISO 3696, sealed, and labelled ready for use The plastics container shall then be capable of

being stored for 42 days at a temperature of (4 ± 2) °C without loss of a mass fraction of more than 2 %

of water from the solution

exchange rates for oxygen and carbon dioxide

6.2.7 Resistance to leakage

When filled to nominal capacity with water as specified in ISO 3696 and sealed, the plastics container

shall not develop leaks under conditions of centrifugation at 5 000 g at 37 °C for 10 min The plastics

container is then squeezed between two plates to an internal pressure equivalent to 50 kPa above atmospheric pressure at (23 ± 5)°C for 10 min No leakage is allowed on visual inspection

For containers of flexible poly(vinyl chloride) (PVC), both tests should be repeated at 4 °C Plastics containers that are normally centrifuged without solution shall be subjected to the same centrifugation conditions as noted above without solution Following this, the plastics container shall withstand an internal pressure equivalent to 50 kPa above atmospheric pressure after filling to nominal capacity

solutions with similar pH, leakage can be detected by pressing the plastics container against sheets of blue litmus paper and observing the development of pink spots on the paper For solutions of other pH, the same method with an appropriate indicator can be used Alternative methods affording at least the same degree of sensitivity may be used

6.2.8 Particulate contamination

Plastics containers shall be manufactured so that contamination with particles is minimized

When tested as described in B.4, the fluid path within the plastics container should be free from visible particles

in the European Pharmacopoeia for parenteral solutions, might be used

6.3 Chemical requirements

6.3.1 Requirements for the raw container or sheeting

The sheeting shall fulfil the requirements given in the relevant pharmacopoeias Alternatively, it may be tested as described in Table 2

Table 2 — Ignition residues for polyolefins and PVC

Test Plastics material Maximum

permissible residue

6.3.2 Requirements for the test fluid

The limits specified in Table 3 shall not be exceeded when the appropriate tests are carried out on the extract obtained in accordance with Annex A